FDA UDI
In Commercial Distribution
🇺🇸 United States
ConFirm 24 Steam Biological Indicators
DI: 10732224000449
·
Model: CSBI25
·
SPS Medical Supply Corp.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- ConFirm 24 Steam Biological Indicators
- Primary DI
- 10732224000449
- Version / Model
- CSBI25
- Catalog Number
- CSBI25
- Company Name
- SPS Medical Supply Corp.
- Labeler DUNS
- 194877072
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2023-08-10
- Public Version
- 1
- Public Version Date
- 2023-08-18
- Public Version Status
- New
- Public Device Record Key
- cacd0d99-25ec-437f-a62b-c682fe526910
Device Description
Self-Contained Biological Indicator, 24 hour incubation
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRC | Indicator, biological sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50732224000447 | GS1 | case | 4 | In Commercial Distribution | |
| Primary | 10732224000449 | GS1 | ||||
| Unit of Use | 00732224000442 | GS1 |
Customer Contacts
- Phone
- +1(585)359-0167
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111515 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature away from sterilants or other chemicals